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Sign in to claim this brandSientra, Inc.
US
Last updated May 24, 2026
What Sientra, Inc. makes
The company manufactures silicone gel-filled breast implants with textured and smooth surfaces, including devices designed for breast reconstruction and augmentation. It also produces skin-port tissue expanders for gradual tissue preparation and single-use invasive breast implant sizers for preoperative assessment. Additional products include tissue expander injection port locators to aid in surgical planning.
These devices are classified as Class III under FDA regulations, requiring premarket approval for most implants, while tissue expanders fall under Class II (Class U for certain custom devices). The portfolio is listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sientra.com
- —
- —
- [email protected]
- Phone
- 888-708-0808
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 010209877
Catalogue (1489)
Page 13 of 30| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Softspan Tissue Expander | SIE-FO-65 | FDA UDI | U | Active |
| SIENTRA Silicone Gel Breast Implant | 20676-500MP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 10521-315HP | FDA UDI | Class III | Unknown |
| SIENTRA Tissue Expander | 819-700U | FDA UDI | U | Unknown |
| SIENTRA Silicone Gel Breast Implant | 20710-400LP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 20646-515HP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 10512-285MP | FDA UDI | Class III | Active |
| OPUS Silicone Gel Breast Implant | 20721-245XP | FDA UDI | Class III | Active |
| OPUS Silicone Gel Breast Implant Sizer | GS10621-280HP | FDA UDI | U | Active |
| SIENTRA Silicone Gel Breast Implant | 10710-195LPP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 20676-310MP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 20646-360MP | FDA UDI | Class III | Unknown |
| SIENTRA Tissue Expander | 810-640U3 | FDA UDI | U | Unknown |
| Softspan Tissue Expander | SIE-CR-045 | FDA UDI | U | Active |
| SIENTRA Vaginal Stent | 3521-095U | FDA UDI | Class II | Unknown |
| OPUS Silicone Gel Breast Implant | 20621-360XP | FDA UDI | Class III | Active |
| Silicone Gel Breast Implant | OBASE-650LP | FDA UDI | Class III | Active |
| OPUS Silicone Gel Breast Implant | RBASE-220HP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 20721-575MP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 10710-110LPP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant Sizer | GS10512-750MP | FDA UDI | U | Active |
| SIENTRA Silicone Gel Breast Implant | 10721-485MP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 20646-190MP | FDA UDI | Class III | Unknown |
| SIENTRA Calf Implant | 402-190U | FDA UDI | Class II | Unknown |
| SIENTRA Silicone Gel Breast Implant | 10610-255LPP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 20621-565HP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 10521-675HP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 10621-505MP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 10610-700LP | FDA UDI | Class III | Active |
| OPUS Silicone Gel Breast Implant | CBASE-600HP | FDA UDI | Class III | Active |
| Softspan Tissue Expander | SRE-LR-200S | FDA UDI | U | Active |
| SIENTRA Silicone Gel Breast Implant | 10721-095MP | FDA UDI | Class III | Unknown |
| SIENTRA Silicone Gel Breast Implant | 10721-195MP | FDA UDI | Class III | Active |
| Silicone Gel Sizer | GSOBASE-410LP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant Sizer | GS10610-280LPP | FDA UDI | U | Active |
| SIENTRA Silicone Gel Breast Implant Sizer | GS10621-275XP | FDA UDI | U | Active |
| Softspan Tissue Expander | SRE-RD-430S | FDA UDI | U | Active |
| Softspan Tissue Expander | SRE-CV-720 | FDA UDI | U | Active |
| SIENTRA Silicone Gel Breast Implant | 10721-650HP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant Sizer | GS10721-535HP | FDA UDI | U | Active |
| SIENTRA Silicone Gel Breast Implant Sizer | GS10512-800MP | FDA UDI | U | Active |
| SIENTRA Silicone Gel Breast Implant Sizer | GS10721-280HP | FDA UDI | U | Active |
| Silicone Gel Sizer | GSOBASE-170LP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 10621-190HP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 10710-600LP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant | 20721-650HP | FDA UDI | Class III | Active |
| SIENTRA Silicone Gel Breast Implant Sizer | GS10610-700LP | FDA UDI | U | Active |
| Silicone Gel Sizer | GSCBASE-240MP | FDA UDI | Class III | Active |
| Softspan Tissue Expander | SRE-RD-380 | FDA UDI | U | Active |
| Silicone Gel Sizer | GSRBASE-445MP | FDA UDI | Class III | Active |
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